JP4959948B2 - Capsule shell - Google Patents

Abstract

The present invention relates to a method of producing a film forming blend of different acyl gellan gums with starch having similar textural and functional properties compared to gelatin. Films prepared using such blends have a high modulus and excellent strength and elongation. The present invention also relates to soft capsules prepared using such blends or films, which have good sealability.

Description

  The present invention relates to a process for preparing blends of various acyl gellan gums with starches and plasticizers that have similar textural and functional properties compared to gelatin. The present invention also relates to methods for making films and soft capsules prepared using such blends, and methods for making such films and capsules.

  Gelatin is used in a variety of pharmaceutical applications, including soft gelatin capsules and hard gelatin capsule shells, as well as many different food applications. Soft capsules are used to encapsulate, for example, a solution or dispersion of a nutritionally active or pharmaceutically active agent in a liquid carrier and are easy to swallow, transportable, and in a substantially taste-free form in a unit dose ( It has many advantages over other dosage forms that allow for accurate delivery of unit doses.

  However, gelatin has many disadvantages, including cost and continuity of safe supply. Bovine sources are also undesirable for certain individuals such as vegetarians and those who wish to maintain the Kosher standard or the Halal standard. In addition, gelatin is prone to cross-linking caused by aging or by reaction with compounds such as aldehydes, which reduces the solubility of gelatin in gastric juice.

  Gelatin allows good sealing of the capsule at temperatures above the melting point of the film, a wet film strong enough to withstand operation in the encapsulation device, solubility in gastric juice, and capsule formation Provides sufficient elasticity. With increasing concerns about bovine spongiform encephalopathy (BSE) in cattle-derived products, many attempts have been made to replace gelatin as present in soft capsules at 25-45%. However, these approaches usually have failed with the resulting product having unacceptably different texture and / or functional properties.

  Surprisingly, it has now been found that the use of film-forming blends with various acylgellan starches provides excellent wet films with high modulus and excellent strength and elongation. Furthermore, soft capsules made of such blends or films have good sealing properties.

  The present invention relates to a process for making film-forming blends of various acylgellan gums with starches and plasticizers that have similar textural and functional properties compared to gelatin and can be used as an alternative to gelatin. is there. Films prepared using such blends have high modulus and excellent strength and elongation. The invention also relates to soft capsules with good sealing properties, prepared using such blends or films.

  Gellan gum, as used herein, refers to an extracellular polysaccharide obtained by aerobic fermentation of the microorganism Pseudomonas elodea in a suitable nutrient medium. Various forms of gellan gum that have been disclosed in the art can be used in the present invention.

On a wet basis, as used herein, is intended to mean at 50% (weight / weight) solids.
A capsule shell, as used herein, is intended to mean a capsule outside of a filling material.

Detailed Description of the Invention The present invention relates to a process for making film-forming blends of various acylgellan gums with starches and plasticizers that have similar textural and functional properties compared to gelatin. Films prepared using such blends have high modulus and excellent strength and elongation. The invention also relates to soft capsules with good sealing properties, prepared using such blends or films.

  The blends of the present invention comprise at least two gellan gums having different acyl contents, one having a high acyl content and the other having a low acyl content. As used herein, high acyl content is intended to mean residual substituents of greater than 40% acetyl and greater than 45% glyceryl per repeat unit. As used herein, low acyl content is intended to mean less than 25% acetyl and less than 15% glyceryl residual substituents per repeat unit.

  The high acyl gellan is used to increase its elasticity and is preferably present in an amount of about 0.3-5% by weight of the composition on a wet basis. In another embodiment, the high acyl gellan is present in an amount of about 0.5-5% by weight of the composition on a wet basis. Low acyl gellan is used to increase its stiffness and is preferably present in an amount of about 0.1 to 4% by weight of the composition on a wet basis. In another embodiment, the low acyl gellan is present in an amount of about 0.1-2% by weight of the composition on a wet basis. In one embodiment, the ratio (weight / weight) of high acyl gellan to low acyl gellan is at least about 0.25: 1.0 and not greater than about 30.0: 1.0. The gellan blend may be used in any amount necessary to achieve the desired gel strengthening effect for both modulus and strength, and in one embodiment about 0.4-10 of the composition on a wet basis. Used in an amount of% by weight. The gellan blend may also be used in an amount of about 1-5% by weight of the composition on a wet basis. The gellan is also present to allow thermoreversibility of the system, which can be enhanced by reducing the amount of low acyl gellan to the lower end of the range.

  The blend also includes at least one starch. As used herein, starch is intended to include all starches derived from natural raw materials that are suitable for use herein. As used herein, native starch is as found in nature. Standard breeding, including those variants, including crossbreeding, translocation, inversion, transformation, or other methods of genetic or chromosomal engineering Also suitable are starches derived from plants obtained by technology. In addition, starches derived from plants grown from artificial mutations and variations of the above general construction, which may be formed by known standard methods of mutation breeding, are also suitable here.

  Typical raw materials for the starch are cereals, tubers, roots, legumes and fruits. Natural ingredients include corn (maize), peas, potatoes, sweet potatoes, bananas, barley, wheat, wheat, rice, oat, sago ( sago, amaranth, tapioca, arrowroot, canna, sorghum, and their waxy and high amylose variants. As used herein, “waxy” is no more than about 10% by weight, specifically no more than about 5% by weight, more particularly no more than about 3% by weight, and most particularly no more than about 1% by weight. It is intended to include the following starch containing amylose. As used herein, “high amylose” includes starch containing at least about 40% by weight, specifically at least 70% by weight, and more particularly at least about 80% by weight amylose. Is intended. As used herein, “amylose-containing” is intended to include starch containing at least about 10% by weight amylose. A suitable starch is an amylose-containing starch in one embodiment, and in another embodiment an amylose-containing starch that is not high amylose.

These starches are known in the art and are described, for example, in U.S. Pat. Nos. 4,465,702, 5,037,929, 5,131,953, and 5, 149,799 may be used to pregelatinize using the technique. See also chapter XXII “Production and Use of Pregelatinized Starch” in Starch: Chemistry and Technology , Vol. III- Industrial Aspects, RL Whistler and EF Paschall, Editors, Academic Press, New York 1967.

  The starch may be native starch or modified starch. Modified starch, as used herein, is intended to include starch that has been modified physically, chemically and / or by hydrolysis. Physical modifications include those by shear or thermal inhibition, such as by the process described in US Pat. No. 5,725,676.

The starch may be chemically modified, including crosslinked, acetylated, organically esterified, hydroxyethylated, hydroxypropylated Phosphorylated, inorganically esterified, cationic, anionic, nonionic, and zwitterionic, and their succinates and substituted succinate derivatives. Such modification is known in the art, for example, Modified Starches: Properties and Uses , Ed. Wurzburg, CRC Press, Inc., Florida (1986).

  These starches may be hydrolyzed, and suitable starches include free-flowing starch or thin-boiling starch prepared by oxidation, acid hydrolysis, enzymatic hydrolysis, heat and / or acid dextrinization. (Thin-boiling starch). These processes are well known in the art.

  Any starch having properties suitable for use herein may be purified by methods known in the art to remove starch odor and color inherent in polysaccharides or produced during chemical processing. Suitable refining processes for treating starch are disclosed in a group of patents represented by EP 554,818 (Kasica et al.). For starches intended for use in either granular or pregelatinized form, alkaline washing techniques are also useful and are described in US Pat. Nos. 4,477,480 (Seidel) and 5,187,272. No. (Bertalan et al.).

  Starches suitable in the present invention include those that are stabilized, including hydroxyalkylated starches such as hydroxypropylated starch or hydroxyethylated starch, as well as acetylated starch. Dextrinized starch is also suitable. In one embodiment, these starches will have a low viscosity with a water fluidity in the range of about 20-90. In another embodiment, the starch has a water flowability in the range of about 65-85. As used herein, water flow properties known in the art are standardized at 30 ° C. using a standard oil with a viscosity of 24.73 centipoise, which takes 23.12 ± 0.05 seconds per 100 revolutions. Also measured using a Thomas Rotational Shear-type Viscometer (commercially available from Arthur A. Thomas, Philadelphia, PA). Accurate and reproducible water flowability by determining the time elapsed between 100 revolutions at different solids levels, depending on the degree of starch conversion, so that the viscosity decreases as the conversion increases. Measurement is achieved. The conversion may be by any method known in the art, including oxidation, enzymatic conversion, acid hydrolysis, heat and / or acid dextrinization.

  The starch may be used in any amount necessary to achieve the desired viscosity and film thickness. The starch is used in one embodiment in an amount of about 15-40% by weight of the composition on a wet basis, and in another embodiment in an amount of about 20-35% by weight. In one embodiment, the starch is added at a ratio of at least about 6: 1 and not more than about 60: 1, based on the weight of the total gellan, on a dry weight basis.

  The blend further comprises at least one plasticizer. The plasticizer used is partly due to the end use, so that it includes polyhydric alcohols such as glycerin, sorbitol, maltitol, propylene glycol, and polyethylene glycol, monosaccharides, and polysaccharides. Is intended. In one preferred embodiment, the plasticizers include glycerin and sorbitol. The plasticizer can be used in any amount necessary to achieve the desired plasticizing effect. The plasticizer is used in one embodiment in an amount of about 10-25% by weight of the composition on a wet basis and in another embodiment in an amount of about 13-22% by weight. The plasticizer is usually added at a dry weight level of about 30-80% by weight of the starch.

  In another embodiment, colloidal particles that are hydrophilic or whose surface is modified to be hydrophilic are added. Such particles include, but are not limited to, cellulose crystal particles as well as silicone particles such as silicon dioxide. In one embodiment, the particles are colloidal silicon dioxide. These particles can be used in any amount necessary to achieve the desired film strength, reduce the drying time of the film, and improve the powder flowability of the blend. The particles are present in one embodiment in an amount of about 0.5-10% by weight of the composition on a wet basis and in another embodiment in an amount of about 0.5-5% by weight. The hydrophilic or surface-modified colloidal particles are at least about 0.2: 1.0 and not more than about 5.0: 1.0, based on the weight of the total gellan, on a dry weight basis. The ratio is added.

  Other additives may optionally be included in the film, as is customary in the industry, as long as it does not adversely affect the film, including colorants, flavors, preservatives, opacifiers , Embrittlement inhibitors, disintegrants, and buffering agents are included without limitation. However, the blend is preferably substantially free of gelatin. The blend contains, in one embodiment, less than 0.1% gelatin, in another embodiment, less than 0.05% gelatin, and in a further embodiment, no gelatin.

  The blend is advantageous in that it has a hot liquid viscosity suitable for casting onto a rotary die drum, a process known in the art for producing soft capsule shells. . Suitable blends, in one embodiment, have a hot viscosity of about 2,000 to about 100,000 centipoise at a solids concentration of about 30-70% and a temperature of about 60-100 ° C. In one embodiment, it has a hot viscosity of about 4,000 to about 40,000 centipoise.

  The dry blend is added to water to form a solid concentration suitable for the film or capsule process used. A solids concentration of about 30-70% is usually suitable for casting the hot liquid onto a cold drum. Other methods known in the art for film formation may be used, including but not limited to extrusion from direct or preformed pellets. The film may be formed during the encapsulation process or may be preformed for later use.

  The resulting wet film has a modulus of about 5-200 kPa. In another embodiment, the wet film modulus is from about 10 to about 250 kPa. Modulus, as used herein, is defined as the film stress per unit stretch strain measured by the Texture Analyzer TA-XT2, using a speed of 2 mm / sec. These films are typically cooled from a film cast temperature of approximately 60-95 ° C. to room temperature before significant loss of moisture.

  The film also has a wet strength of about 10 to about 1,000 kPa. In another embodiment, the wet strength is from about 20 to about 500 kPa. Wet strength, as used herein, is defined as the area by the stress / strain curve for the elongation test, where the strain is a unitless%.

  The film further has a dry modulus of about 0.5 to about 50 MPa. In another embodiment, the dry modulus is from about 1 to about 20 MPa. Dry modulus, as used herein, is defined as the modulus of a film that has been dried for more than 12 hours at 50% relative humidity. The film also has a dry strength of about 0.1 to about 100 MPa. In another embodiment, the dry strength is from about 0.2 to about 50 MPa. Wet films usually have a breaking elongation of about 50% to about 500%, and dry films usually have a breaking elongation of about 20% to about 150%.

  The nature of the film allows it to be used to form capsule shells that are substantially free of gelatin using techniques known in the art, including also on a rotating device. These soft capsule shells have the same excellent properties and excellent sealing properties as the film. In some embodiments, the capsule shell can be sealed at a temperature above about 40-95 ° C. with a moisture content of about 20-60% by weight. In a further embodiment, the capsule shell can be sealed with a moisture content of about 30-55 wt% at similar temperatures. In another embodiment, the sealing temperature is in the range of 45-75 ° C. An excellent seal, as used herein, is intended to mean a seal that resists further modification and transportation of the capsule so that the capsule can reach the consumer without leaking or tearing. ing.

  The capsule shell formed using the rotary die process has a thickness of about 0.25 to 1.8 mm, and in another embodiment about 0.6 to 1.4 mm, Looks and feels similar. The filler for these soft capsule shells may be any commonly used in the art, including oils, hydrophobic liquids and emulsions containing the active ingredient. Fillers can include cosmetics, bath oils, foods, vitamins, detergents, liquids, semisolids, flavorings and pharmaceuticals. After filling, the capsules may be dried using conventional techniques in the art including shelf drying.

The following embodiments are presented with reference embodiments to further illustrate the present invention and should not be construed as limiting in any way.

1. A composition comprising:
(A) high acyl gellan gum;
(B) low acyl gellan gum;
(C) starch; and (d) plasticizer.

2. The composition of embodiment 1, wherein the high acyl gellan gum has a residual substituent of greater than 40% acetyl and greater than 45% glyceryl per repeat unit.

3. The composition of embodiment 1, wherein the low acyl gellan gum has less than 25% acetyl and less than 15% glyceryl residual substituents per repeat unit.

4). The composition of embodiment 1, wherein the high acyl gellan gum is present in an amount from about 0.3 to about 5% by weight of the composition on a wet basis.

5). The composition of embodiment 1, wherein the low acyl gellan gum is present in an amount of about 0.1 to about 4% by weight of the composition on a wet basis.

6). (A) high acyl gellan gum;
(B) low acyl gellan gum;
(C) a composition comprising starch and a plasticizer, wherein the high acyl gellan gum is present in an amount of from about 0.3 to about 5% by weight of the composition on a wet basis; In an amount of from about 0.1 to about 4% by weight of the composition on a wet basis.

7). The composition of embodiment 1, wherein the ratio of high acyl gellan to low acyl gellan is from about 0.25: 1.0 to about 30.0: 1.0.

8). The composition of embodiment 6, wherein the ratio of high acyl gellan to low acyl gellan is from about 0.25: 1.0 to about 30.0: 1.0.

9. The composition according to aspect 1, wherein the starch is an amylose-containing starch.

10. The composition according to embodiment 9, wherein the starch is a stabilized starch.

11. Embodiment 11. The composition of embodiment 10, wherein the starch is selected from the group consisting of hydroxypropylated starch, hydroxyethylated starch, acetylated starch, and mixtures thereof.

12 Embodiment 9. The composition of embodiment 8, wherein the starch is selected from the group consisting of hydroxypropylated starch, hydroxyethylated starch, acetylated starch, and mixtures thereof.

13. The composition according to aspect 1, wherein the starch is dextrinized starch.

14 The composition of embodiment 1, wherein the starch is present in an amount of about 15 to about 40% by weight of the composition based on wet film.

15. Embodiment 9. The composition of embodiment 8, wherein the starch is present in an amount of about 15 to about 40% by weight of the composition based on wet film.

16. Embodiment 12. The composition according to embodiment 11, wherein the starch is present in an amount of about 15 to about 40% by weight of the composition based on wet film.

17. The composition of embodiment 1, wherein the plasticizer is glycerin and is present in an amount of about 30-80% by weight of the starch.

18. Embodiment 9. The composition of embodiment 8, wherein the plasticizer is glycerin and is present in an amount of about 30-80% by weight of the starch.

19. Embodiment 12. The composition according to embodiment 11, wherein the plasticizer is glycerin and is present in an amount of about 30 to 80% by weight of the starch.

20. The composition according to aspect 1, further comprising colloidal particles that are hydrophilic or have a surface modified to be hydrophilic.

21. 9. The composition according to aspect 8, further comprising colloidal particles that are hydrophilic or have a surface modified to be hydrophilic.

22. 12. The composition according to aspect 11, further comprising colloidal particles that are hydrophilic or have a surface modified to be hydrophilic.

23. A capsule shell comprising a composition comprising:
(A) high acyl gellan gum;
(B) low acyl gellan gum;
(C) starch; and (d) plasticizer.

24. (A) high acyl gellan gum;
(B) low acyl gellan gum;
(C) starch; and (d) a capsule shell containing a plasticizer, wherein the high acyl gellan gum is present in an amount from about 0.3 to about 5% by weight of the composition on a wet basis, Low acyl gellan gum is present in an amount of from about 0.1 to about 4% by weight of the composition on a wet basis, wherein the ratio of high acyl gellan to low acyl gellan is from about 0.25: 1.0 to about 30. 0.0: 1.0 capsule shell.

25. (A) high acyl gellan gum;
(B) low acyl gellan gum;
(C) starch; and (d) a capsule shell containing a plasticizer, wherein the starch is from hydroxypropylated starch, hydroxyethylated starch, acetylated starch and mixtures thereof. A capsule shell, which is a stabilized amylose-containing starch selected from the group consisting of:

  The following examples are presented to further illustrate the present invention and should not be construed as limiting in any way. All percentages used are on a weight basis.

The following viscosity measurements are used throughout the examples.
The solution cooked in the flow bath is quickly poured into a preheated (up to 90 ° C.) heat cell. The temperature of the solution was then stabilized at 90 ° C. The static viscosity was measured using Brook Field Viscometer DV-II + and spindle number 21 or 27.

The following ingredients are used throughout the examples.
Starch A: Hydroxypropylated corn starch having a water fluidity of 80.
Starch B: Hydroxypropylated waxy corn starch having a water fluidity of 60.
Starch C: Hydroxypropylated waxy corn starch having a water flow of 75 and soluble in cold water.
Starch D: Highly degraded waxy corn starch.
Starch E: Hydroxypropylated tapioca starch having a water fluidity of 40.
Starch F: Hydroxypropylated waxy starch with a water fluidity of 70.
Starch G: Hydroxypropylated waxy starch with a water fluidity of 65.
Kelcogel LT 100: High acyl gellan gum commercially available from CP Kelco (Wilmington, Del.).
Kelcogel F: A low acyl gellan gum commercially available from CP Kelco (Wilmington, Del.).
Aerosil 200: A silica filler commercially available from Degussa (Akron, Ohio).
Avicel PH101: Microcrystalline cellulose particles commercially available from FMC (Philadelphia, PA).
Glycerin: Commercially available from Aldrich (Milwaukee, Wis.).
Sorbitol: Commercially available from Aldrich (Milwaukee, Wis.).

Example 1-Blend preparation a. The powder blend was premixed with 1.5 g Kelcogel LT100, 1 g Kelcogel F, 1 g Aerosil 200, and 30 g Starch A. The powder mixture was added into a beaker containing 18 g glycerin dissolved in 48.5 g distilled water. The entire mixture was blended to form a thick paste. Next, the paste was cooked while stirring at about 90 ° C. to 100 ° C. for 1 to 2 hours using a steam bath until the solution became smooth and nearly transparent. Its final viscosity was 30,000 to 50,000 centipoise.

b. Example 1a was repeated except that 49.5 g of water was used without using Aerosil. The viscosity and wet film strength of the finished product were slightly reduced as seen from Example 1a.

c. Example 1a was repeated except that starch A was replaced with starch E. The viscosity of the finished product was 70,000 centipoise. The wet film strength was slightly higher than that of Example 1a.

d. Example 1a was repeated except that glycerin was used in an amount of 13 g and distilled water was used in an amount of 53.5 g. The viscosity of the resulting product was similar to that of Example 1a, and the dry film had a higher modulus and less elongation than that of Example 1a.

e. Example 1a was repeated except that 15 g sorbitol was used instead of glycerin and distilled water was used in an amount of 51.5 g. The resulting product had a viscosity similar to that of Example 1a.

f. Example 1a was repeated except that the amounts of Kelcogel LT 100 and Kelcogel F were 2 g and 0.5 g, respectively. Compared to that of Example 1a, the viscosity of the solution increased, the wet film strength increased, and the sealability improved.

g. Example 1a was repeated except that the amounts of starch and water were 45 g and 33.5 g, respectively. Its viscosity was approximately 15,000 centipoise and its wet film strength was improved from that of Example 1a.

h. Example 1a was repeated except that 3 g of Avicel PH101 was used instead of Aerosil and 46.5 g of water was used. The viscosity of the solution increased slightly from that of Example 1a and the wet film strength improved from that of Example 1a.

i. Example 1a was repeated except that sodium chloride was added to the water-glycerin mixture so that the final paste had a 10 mM sodium chloride concentration. Its wet film strength was improved from that of Example 1a.

j. Example 1a was repeated except that the calcium nitrate was added to the water-glycerin mixture so that the calcium paste had a 10 mM concentration in the final paste. Its wet film strength was improved from that of Example 1a.

k. Example 1a was repeated except that Kelcogel F was replaced with guar gum. The wet film strength decreased from that of Example 1a. The example was then repeated using agar instead of guar gum, but the wet film strength also decreased.

l. Example 1a was repeated except that the amount of water was 60 g. The viscosity of the solution was approximately 5,000 centipoise. The wet film strength decreased. In order to seal the capsule, it was necessary to further dry the film.

Example 2-Preparation of the film The solution produced from Example 1 was quickly degassed while maintaining its temperature, and a vegetable oil was drawn using a film drawer with a 0.6-1.4 mm gap. Alternatively, the film was cast on a glass or metal substrate covered with a thin layer of other release agent.

  A sample of each wet film was obtained immediately after the wet film was cooled to room temperature of approximately 22.5 ° C. A sample of dry film was obtained after drying for about 24 hours at 22.5 ° C. and 50% relative humidity.

Example 3 Mechanical Test The film samples were cut to a length of 55 mm with a width of 20 mm. After stacking them on Texture Analyzer TA-XT2, the films had an initial film length of 20 mm. They were then stretched to break at a constant rate of 2 mm / min. The stress was measured using a 5 kg Texture Analyzer transducer. Their stress / strain curves were automatically recorded.

  The modulus was calculated by dividing the maximum strength by the breaking elongation. Film strength was calculated by integrating the area under the stress / strain curve.

Example 4 Mechanical Properties From the measurement results of Example 1a, the wet film modulus of 28 kPa, the wet film strength of 98 kPa, the wet film breaking elongation of about 320%, the dry film modulus of 4.5 MPa, the dry film strength of 25 MPa And a dry film breaking elongation of about 59% was obtained.

Example 5-Preparation of filled capsules 5a. Capsules were formed using the wet film of Example 2, on a manual molding machine, and using vegetable oil as an example of a filler. Initially, the film was placed on a heated metal with small cavities, and vacuum was used to acclimate the wet film to the cavity surface. The oil was then quickly added to fill the cavity. Another wet film was placed on top of it. Finally, a heated metal piece was used to press against the bottom of the metal piece. A capsule was formed and removed from the molding machine. The manual molding machine was maintained at 45-75 ° C.

5b. Capsules were formed as in 5a except that the moisture in the wet film was reduced. The seal was improved and the capsule was stronger.

Example 6 Ribbon Adjustment A long ribbon was made using a roller coater equipped with a sample feeder with controlled temperature. The ribbons were cast on a polyethylene terephthalate (PET) substrate with a one-sided release liner. The film was passed through a tunnel dryer to remove the moisture.

6a. These finished ribbons were fed directly to a capsule forming machine to form capsules.

6b. Those dried ribbons were stored for later use. Rewetting, such as running the film in water steam, was useful to provide sufficient flexibility to the film for capsule formation after storage.

Example 7-Capsule Properties These capsules can be formed into various sizes and shapes by using various dies on a capsule forming machine using a drum coater. The capsules were clear and slightly translucent. The dried capsules were stable for at least 6 months and exhibited moderate solubility in both water and gastric juice.

Claims (6)

A capsule shell comprising a composition, the composition comprising:
a. High acyl gellan gum present in an amount of 0.3-5% by weight of the composition on a wet basis;
b. Low acyl gellan gum present in an amount of 0.1 to 4% by weight of the composition on a wet basis;
c. Starch; and
d. Containing a plasticizer present in an amount of 30-80% of the starch on a dry weight basis , wherein the starch is from hydroxyalkylated starch, acetylated starch, dextrinized starch, and mixtures thereof A capsule shell selected from the group consisting of:   The high acyl gellan gum has a residual substituent of greater than 40% acetyl and greater than 45% glyceryl per repeat unit, and the low acyl gellan gum is less than 25% acetyl and less than 15% per repeat unit The capsule shell of claim 1 having a residual substituent of   The capsule shell according to claim 1 or 2, wherein a weight ratio of the high acyl gellan to the low acyl gellan is 0.25: 1.0 to 30.0: 1.0.   4. The starch according to any one of claims 1 to 3, wherein the starch is a stabilized starch selected from the group consisting of hydroxypropylated starch, hydroxyethylated starch, acetylated starch and mixtures thereof. Capsule shell as described in.   Capsule shell according to any one of claims 1 to 4, wherein the starch is present in an amount of 15 to 40% by weight of the composition on a wet film basis.   The capsule shell according to any one of claims 1 to 5, wherein the plasticizer is glycerin.